Fahl 25900, Instructions For Use Manual

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15
EN
4. To achieve better lubrication of the applicator for advancing the voice
prosthesis, it is recommended to use the FAHL
®
OPTIFLUID
®
LUBRI-
CANT GEL included in delivery.
5. Use the placement instrument to push the voice prosthesis forward by
approx. 1 cm into the slotted opening of the applicator .
6. Marked positions 1 and 2 are shown on the placement instrument.
Now guide the placement instrument with the voice prosthesis through
the applicator up to marked position 1 .
7. The voice prosthesis can now be introduced into the shunt channel us -
ing the applicator.
8. Cautiously introduce the tip of the applicator into the shunt channel .
9.
Now slowly advance the voice prosthesis through the applicator up to
marked position 2.
The oesophageal flange will open in the lumen of the oesophagus
.
10. Now cautiously retract the applicator via the placement instrument.
The tracheal flange opens in the lumen of the trachea.
The applicator can be retracted via the placement instrument
.
11. The correct position of the voice prosthesis is verified by rotating the
voice prosthesis with the placement instrument or by pulling slightly .
12. Rotate the voice prosthesis into position such that the safety thread is in
the 12 o'clock position.
13. Fix the safety thread in place with an atraumatic clamp and remove the
placement instrument .
14. Perform a phonation test. Check the leakproofness of the voice prosthe -
sis with a swallowing test.
15. If the voice prosthesis is in the correct position, cut the safety thread flush
with the tracheal flange
.
8.2.5 LARYVOX
®
INSERTER SPECIAL REF 25920 (blue)
The LARYVOX
®
INSERTER SPECIAL consists of a placement instrument
with a curved base for introducing a voice prosthesis into the shunt chan -
nel which is to be introduced using the gel capsule technique.
FIELDS OF APPLICATION:
• Fistula in low position or with oblique course
• Constricted shunt channel/fistula
• Voice prosthesis replacement in particularly small tracheostomas to op -
timise viewing conditions
PLEASE NOTE!
The LARYVOX
®
INSERTER SPECIAL is used only and exclusively for the
anterograde placement of a voice prosthesis using the gel capsule technique
in the scope of voice prosthesis replacement.
Heed the instructions for use of the voice prosthesis as well as these instruc -
tions for use for inserting voice prostheses using the gel capsule technique!
INSTRUCTIONS:
1. After folding the voice prosthesis into the gel capsule, mount it with its
tracheal flange on the head of the placement instrument .
2. Fix the safety thread of the voice prosthesis in place at the intended po -
sition + .
3. Check to ensure that the voice prosthesis is securely seated on the
placement instrument.
N
WARNING!
Should the voice prosthesis come loose from the shunt channel or
during insertion of the placement instrument, there is a risk of aspi -
ration.
In the event of aspiration, it must be attempted to expel the voice pros -
thesis through strong coughing.
If the voice prosthesis cannot be coughed out, it must immediately be
removed surgically.
4. The voice prosthesis can now be introduced into the shunt channel .
5. The correct position of the voice prosthesis is verified after dissolution
of the gel capsule by rotating the voice prosthesis with the placement
instrument or by pulling slightly .
6. If the voice prosthesis can be easily rotated, fix the safety thread in place
using an atraumatic instrument such as e.g. LARYVOX
®
TWEEZERS
( REF 35000 ) and cautiously remove the placement instrument .
7. Perform a phonation test and, where appropriate, a swallowing test with
the patient in order to verify the leakproofness.
8. If the voice prosthesis is in the correct position, cut the safety thread flush
with the tracheal flange .
9. CLEANING & DISINFECTION
PLEASE NOTE!
LARYVOX
®
INSERTER s (- EXPERT , - EXPERT SMALL , - UNIEK , - SPE-
CIAL ) must not be cleaned or disinfected. Sterilisation and reuse can impair
the function and is therefore not permissible either.